Effect of Photodynamic Therapy on Soft Tissue Healing After Tooth Extraction at Sites of Periodontal Infection

Effect of Photodynamic Therapy on Soft Tissue Healing After Tooth Extraction at Sites of Periodontal Infection: a Randomized Controlled Clinical Trial

Main Purpose: To evaluate the effect of photodynamic therapy on soft tissue healing after tooth extraction at periodontal infection site, and to compare the effect on pain degree and bone tissue remodeling after tooth extraction.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw.

Detailed Description

The aim of this study is to evaluate the effect of photodynamic therapy (PDT) on soft tissue healing and bone remodeling in tooth extraction sockets after tooth extraction. The enrolled patients will be randomized into two groups. The control group used conventional tooth extraction to clean the wound, and the experimental group used photodynamic therapy to help clean the wound. Seven days and 14 days after extraction, the area of extraction socket was measured, the healing rate of extraction socket was calculated, and Landry, Turnbull and Howley soft tissue healing index was measured. The degree of pain was recorded at 6h, 1 day, 2 days and 3 days after tooth extraction. Bone remodeling indexes were measured at 1 month after tooth extraction.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age range from 18 to 65 years old;
• Patients with extensive periodontitis of the whole mouth;
• There was a deep periodontal pocket with PD≥5mm and at least one adjacent tooth at the extraction site;
• Periodontitis was controlled, and the extraction site and adjacent teeth were not in the acute inflammation or infection stage;
• The extraction site has a hopeless prognosis or no preservation value, and it is the first and second molars or maxillary wisdom teeth that erupt in a positive position

Exclusion Criteria:

• pregnant and lactating women;
• patients with systemic diseases that may affect the ability of postoperative healing (such as patients with radiotherapy and chemotherapy, history of hematological diseases, and uncontrolled disease) Diabetes mellitus, etc.);
• long-term use of drugs known to affect bone metabolism or mucosal healing such as bisphosphonates and non-steroidal anti-inflammatory drugs;
• smoking > 10 cigarettes per day;
• root breakage or gingival tear occurred during tooth extraction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Debridement of tooth extraction sockets was assisted by photodynamic equipment	Drug: Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw.; The tooth extraction sockets were filled with photosensitizer methylene blue. The guide head of the laser periodontal therapy instrument (Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw.) was placed in the tooth extraction sockets to probe and move around the tooth extraction sockets for 1 minute. At the end of irradiation, a cotton ball dipped in saline was used to wipe the guide head and rinse the photosensitizer out of the socket; Other Names: The disposable dental Treatment Kits Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China）
No Intervention: control group; Routine tooth extraction and debridement were performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing rate at 7 days	（The size of the tooth extraction wound area at 7 days）/(The size of the tooth extraction wound area at baseline)	baseline;at 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Landry, Turnbull and Howley soft tissue healing index	Soft tissue index of healing wound after tooth extraction	baseline, at 7 days; at 14days
Degree of pain	VAS score was used to evaluate the pain degree of tooth extraction trauma. A score of 0 indicates no pain and a score of 10 indicates severe pain.	at 6 hours; at 1 day; at 2 days; at 3 days
Changes in Bone Mineral density	Changes in Bone Mineral density	baseline, at 1 month
Bone height changes	Bone height changes	baseline, at 1 month
Wound healing rate at 14 days	（The size of the tooth extraction wound area at 14 days）/(The size of the tooth extraction wound area at baseline)	baseline;at 14 days

Collaborators and Investigators

• Sponsor: The Dental Hospital of Zhejiang University School of Medicine
• Investigators: Principal Investigator: Peihui Ding, Doctor, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: DHZhejiangU-2022(197)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No